Sierra QMS
Quality Management System in JIRA

FDA Compliance using the tools you love!

Healthcare and life science Quality Management System based on Atlassian Jira for medical device, biotech, pharmaceutical, and clinical research companies

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Sierra QMS customized just for you

Designed for healthcare and life science companies of all shapes and sizes.

Medical Device

Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device.

Pharmaceutical & BioTech

Track SOPs, GxP system inventories, and all components of your System/Device Life Cycle with workflows designed to comply with 21 CFR Part 11, GLP, GCP, and other industry standards.

Clinical Research

Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports.

The Compliance Container

A Quality Management System tailored to fit you that can be deployed in any environment (local servers, cloud, and data centers).

Customizable Compliance Workflow Management
  • Designed for you

    Built to automatically scale with your organization through built in recommendations and workflows

  • FDA audit ready

    Designed to easily align with current FDA guidance

Publish Policies & Procedures

Generate all your policies, procedures, and artifacts into traditional documents for audit review.

Manage and configure all compliance policies, procedures, and artifacts electronically.
Sit back and have some coffee :)Publish generated policies, procedures, and artifacts for audit review.

Automated Training

As you scale and improve your workflows, policies and procedures, keep your team trained automatically.

Created with Sketch. Remind Me Tomorrow Start Training Ready to start your training? Training: Risk Assessment SOP Updated
Easy to use training module built into JIRA

Test Automation

Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals.

Test automation built into JIRA
Automated testing on mobile apps
Automated testing on medical devices

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